Kornimate/medical-research-clean huggingface dataset:
quantification of ue use and effects of feedback in the home setting

Conditions: Stroke

Summary: the investigators are proposing a pilot study, the purpose of which is to use accelerometers to quantify ue use (1 and two hand use) in people post-stroke from which the investigators will develop use-based feedback to improve recovery in the home setting. the objectives of this pilot study are to: i.) determine the feasibility of using accelerometers to quantify amount of ue use in the home setting in individuals chronic post-stroke, ii.) quantify and compare the unilateral activity of the weaker (paretic) versus stronger (non-paretic) ues, and iii.) assess the effect of a 7 sessions of in-home accelerometer used-based feedback on unilateral and bilateral ue use. iv.) assess kinematic, kinetic, and emg data during ue movements unilaterally and bilaterally in subjects post-chronic stroke pre and post feedback.


Eligibility criteria:
inclusion criteria: * subjects post-stroke * chronic post ischemic or hemorrhagic cortical or subcortical stroke * 25 - 100 years old * upper extremity impairment * subjects will need to be able to flex their paretic shoulder and their elbow \> 40° without assist * able to follow 2-step commands * community dwelling with or without assistance * intact superficial light touch sensation in both upper extremities * must also have some movement in both arms exclusion criteria: * can't currently have another neuromuscular disorders such as spinal cord injury, traumatic brain injury, parkinson disease or multiple sclerosis * no upper extremity injury within the last 3 months
double-blind comparative study of e3810 tablets (10 or 20 mg b.i.d.) to evaluate efficacy and safety in patients with refractory reflux esophagitis

Conditions: Refractory Reflux Esophagitis

Summary: the purpose of this study is to evaluate the efficacy and safety of e3810 tablets in patients with proton pump inhibitor-resistant reflux esophagitis.

this is a multicenter, randomized, double-blinded study. the efficacy with e3810 20 mg once daily is compared with e3810 20 mg twice daily and 10 mg twice daily using endoscopic recovery. the frequency of adverse event, etc., will be compared among 3 groups for safety assessment.

Eligibility criteria:
inclusion criteria: * patients who have mucosal breaks (erosions, ulcers) on endoscopy and are diagnosed with reflux esophagitis. * proton pump inhibitor standard dose-resistant reflux esophagitis. * patients who are 20 years and older when informed consent is obtained. exclusion criteria: * patients with a concurrent severe illness, serious heart disease, comorbid severe disease such as hematology, kidney disease, or liver disease. * patients with malignancy. * patients who are taking another trial drug or the interval between the end of treatment and screening is less than 12 weeks.

Keywords: reflux esophagitis rabeprazole gerd japan
using visual feedback to influence rapid response in the treatment of eating disorders

Conditions: Bulimia Nervosa; Binge Eating Disorder

Summary: this study has two aims: 1) to test the validity of an eating disorder symptom checklist against an established clinical interview; and 2) to examine whether providing eating disorder patients with visual graphs of their symptom frequency in the early sessions of active treatment will lead to higher numbers of patients achieving a "rapid response" (65% reduction in symptoms in the first 4 weeks of treatment). groups where patients receive visual graphs of symptom frequency will be compared with groups where patients do not receive visual graphs of symptom frequency on rates of rapid response to cognitive behavior treatment for eating disorders.

there is a growing body of research indicating that the best predictor of treatment outcome for eating disorders is a "rapid response" - or a 65% drop in symptoms such as binge eating or purging - in the first four weeks of cognitive behavior treatment (cbt). research is only now beginning to look at whether it is possible to increase the number of rapid responders by directly encouraging this behavior in patients. this study has two aims: 1) to validate information obtained about symptoms in a weekly symptom checklist (wsc) against information obtained in clinical interview; and 2) to examine whether, in a context where rapid response is being discussed and actively encouraged, the rates of rapid response can be improved by providing patients with visual of symptom change in the first weeks of treatment. investigators hypothesize that there will be significant correspondence between the wsc and clinical interview. investigators also hypothesize that being given a visual of symptom change in the first weeks of treatment will result in higher rates of rapid response in patients being encouraged to achieve these objectives; and that rapid response will be related to higher rates of symptom remission at the end of treatment. participants will be 40 patients diagnosed with bulimia nervosa, binge eating disorder or purging disorder. these patients will be spread across 6 treatment groups. three groups will be randomly selected (balanced across clinicians) to either receive or not receive visual feedback on change in frequency of symptoms based on their responses to the weekly symptom checklist (wsc).

Eligibility criteria:
inclusion criteria: * bmi (body mass index) over 19 * diagnosis of bulimia nervosa, binge eating disorder, or other specified feeding and eating disorder (osfed) purging disorder. exclusion criteria: * bmi below 19

Keywords: rapid response eating disorders cognitive behavior therapy bulimia nervosa binge eating disorder purging disorder
a single group study to evaluate the effects of a vaginal probiotic on vaginal and digestive health

Conditions: Irritable Bowel Syndrome; Vaginal Health

Summary: this is a virtual single-group study that will last 12 weeks. participants will take 1 capsule every day, with water. questionnaires will be completed at baseline, 2 weeks, 4 weeks, and 12 weeks.


Eligibility criteria:
inclusion criteria: 1. women aged 18-40 2. self-reported concerns with vaginal odor, itchiness, dryness, or discharge 3. self-reported issues associated with bacterial vaginosis, reporting three of the following symptoms: * unusual vaginal discharge ( thin, grayish-white or milky discharge that has a strong, fishy odor) * changes in vaginal odor (i.e. an unpleasant "fishy" odor) * vaginal itching or irritation * discomfort or burning sensation during urination 4. self-reported symptoms associated with irritable bowel syndrome (ibs), including three of the following symptoms: * abdominal pain or discomfort * changes in bowel habits i.e. diarrhea, constipation, or a combination of both. * bloating * gas or flatulence * changes in stool appearance * mucus in the stool 5. generally healthy - don't live with any uncontrolled chronic diseases 6. willing to avoid the use of any intra-vaginal products (such as vaginal creams, gels, or medications) as well as suppositories during the study product use exclusion criteria: 1. any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders 2. planning to undergo any procedure related to their reproductive health. 3. started any new medications or supplements that target vaginal health or ibs in the past 3 months. 4. anyone with known severe allergic reactions 5. women who are pregnant, breastfeeding, or attempting to become pregnant 6. unwilling to follow the study protocol 7. anyone with a history of vaginal, cervical, vulvar, uterine, or ovarian cancer 8. anyone who has changed or stopped taking hormonal birth control in the last 3 months
vascular endothelial growth factor (vegf) levels in brain tumor patients

Conditions: Glioma; Meningioma

Summary: objectives: this study is looking at the level of vascular endothelial growth factor (vegf) circulating in the blood stream of patients diagnosed with either a meningioma or a glioma. the questions that will be addressed include: 1. can vegf level alert us to tumor progression or recurrence before mri changes occur? 2. is the vegf level an indicator of the response to treatment? 3. does the vegf level correlate with tumor histology and behavior? 4. is there a relationship between vegf level and outcome?


Eligibility criteria:
inclusion criteria: * any patient presenting with glioma or meningioma exclusion criteria: * a different type of brain tumor

Keywords: glioma meningioma vegf
phase ii study of arginine butyrate with or without epoetin alfa in patients with thalassemia intermedia

Conditions: Beta-Thalassemia

Summary: objectives: i. determine whether arginine butyrate with or without epoetin alfa can stimulate gamma-globin chain production to a degree that decreases anemia and results in hematologic improvement in patients with thalassemia intermedia. ii. determine whether a proportional increase in gamma-globin synthesis and mrna and an improvement in nonalfa and alfaglobin chain imbalance by at least 10% over baseline correlate with improved hematologic response in these patients when treated with this regimen. iii. determine whether a decrease in hemolysis, as assayed by a decrease in ldh, compared to baseline levels correlates with improved hematologic response in these patients when treated with this regimen. iv. determine whether any particular genotypes are more responsive than others to this therapy in these patients. v. determine whether baseline epoetin alfa levels, gender, and/or baseline reticulocyte counts (or percent circulating nucleated erythroblasts) correlate with improved hematologic response in these patients when treated with this regimen.

protocol outline: this is a multicenter study. patients receive arginine butyrate iv over 6-14 hours on days 1-5 of weeks 1-4 and 7-10. patients then receive maintenance arginine butyrate iv over 6-14 hours on days 1-4 of weeks 13, 15, 17, 19, 21, 23, and 25. patients who have no medical contraindications (e.g., paraspinal extramedullary hematopoiesis, hypertension, or poorly controlled congestive heart failure) may continue therapy. patients receive arginine butyrate iv over 6-14 hours on days 1-4 of weeks 27, 29, 31, 33, 35, 37, and 39 and epoetin alfa intramuscularly (im) or subcutaneously (sc) three times weekly on weeks 27-40. patients may continue to receive epoetin alfa im or sc alone three times weekly on weeks 41-52. patients with severe anemia (hemoglobin less than 7 g/dl) may receive epoetin alfa alone on weeks 1-12 before arginine butyrate induction therapy. patients who complete therapy at week 26 are followed every 2 weeks for 2 months. patients who complete therapy at week 40 are followed monthly for 2 months.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- * diagnosis of thalassemia intermedia with hemoglobin no greater than 10 g/dl two beta thalassemia mutations * must have undergone prior splenectomy or have no palpable spleen --prior/concurrent therapy-- * at least 3 months since prior red blood cell transfusion --patient characteristics-- * performance status: swog 0-2 * hematopoietic: no severe iron overload or ferritin greater than 5,000 ng/ml * hepatic: normal hepatic function no active hepatitis * renal: normal renal function * other: not pregnant or nursing negative pregnancy test fertile patients must use effective contraception must be willing to have vascular access placed no viral disease no contraindication to study compliance

Keywords: genetic diseases and dysmorphic syndromes hematologic disorders rare disease thalassemia intermedia
the natural history of parkinson's disease-associated spinal disorders

Conditions: Parkinson Disease; Idiopathic Parkinson Disease

Summary: this is a prospective single-institution longitudinal study to access quality of life and serial imaging and biodynamic testing to assess spinal disorders associated with parkinson's disease patients.

this is a prospective single-institution longitudinal study to access quality of life with promis testing, odi, ndi, vas and short form 36 health physical component score. the study will also include serial radiographic assessments and biodynamic force plate and hand dynamometer testing. this study will follow for five years post-consent.

Eligibility criteria:
inclusion criteria: * diagnosis of idiopathic parkinson disease early to mid-disease course (hoehn and yahr scale 1-3) age 18-75 exclusion criteria: * prior spinal fusion diagnosis of ankylosing spondylitis, diffuse idiopathic spinal hyperostosis (dish), or other systemic condition that affects spinal function inability to consent current incarceration presence of other medical condition or neurologic condition that would hinder ability to perform biodynamic testing
effectiveness of massage therapy with active component and therapeutic exercise in cervical pain

Conditions: Neck Pain; Chronic Pain

Summary: it is an interventional study that proves the eficacy of the manual therapy with active manual therapy and combined with exercise in cervical pain.

the study will be divided in two different groups: * a control group (group a) : they will receive a treatment with manual therapy and physical exercise. * an experimental group (group b) : they will receive the previous treatment, but also the pacient's do active muscle active contraction. the exercise is compound by a home program of several exercises with diferent difficulties. the contraction will consist on a combination of concentric and isometric work. being the patient's pain threshold the one that will guide us to the choice of the predominance of concentric or isometric contraction . both groups will be joined by a five-minute work on pain education.

Eligibility criteria:
inclusion criteria: * accept to participate in the study, through informed consent * subjects with chronic nonspecific neck pain lasting equal to or more than 3 months exclusion criteria: * present neck pain caused by serious pathology such as: inflammatory, congenital, infectious, metabolic and neoplastic diseases. * cervical pathology of traumatic origin with less than 6 months of evolution. * rheumatic diseases. * neck pain with neurological signs such as: radiculopathy and myelopathy. * previous surgery of the cervical spine. * pregnancy. * have received physiotherapeutic treatment in the cervical region during the month prior to the inclusion of the study. * have the intention of receiving other physiotherapeutic treatments different from the one proposed during the study period. * present serious mental disorders.

Keywords: neck pain exercise endurance training intervention
schistosoma haematobium infections and praziquantel

Conditions: Schistosomiasis

Summary: the purpose of this study is to evaluate the impact of praziquantel for the treatment of schistosoma haematobium infection among schoolchildren in al salamania in central sudan.

a longitudinal study will be conducted to evaluate the impact of praziquantel for the treatment of schistosoma haematobium infection among schoolchildren in al salamania in central sudan. a cohort of schoolchildren (6-15 years of age) was investigated before and 1 year after treatment with a single dose of praziquantel 40mg/kg.

Eligibility criteria:
inclusion criteria: * school children exclusion criteria: * taking praziquantel

Keywords: schistosoma haematobium schoolchildren central sudan praziquantel
use of a biofilm antimicrobial susceptibility assay to guide antibiotic therapy

Conditions: Cystic Fibrosis

Summary: the purpose of this study is to determine whether choosing antibiotics based on a biofilm antimicrobial susceptibility assay rather than a conventional planktonic antimicrobial susceptibility assay to treat cf patients with chronic p. aeruginosa infection with an acute pulmonary exacerbation is a safe intervention that will result in improved microbiological and clinical outcomes and decrease markers of pulmonary inflammation.

cystic fibrosis (cf) is the most common fatal genetic condition in the caucasian population and affects over 3,000 canadians. respiratory failure caused by chronic pulmonary infection is the primary cause of death in cf patients. the improved life expectancy of cf patients in the past several decades is due in part to the more aggressive use of antibiotics in the treatment of respiratory infections. however, there is currently no antimicrobial susceptibility assay that can predict which antibiotics will result in improved patient outcomes. since pseudomonas aeruginosa is known to grow as a resistant biofilm in the cf lung, antimicrobial susceptibility testing based on biofilm growth of p. aeruginosa may lead to different antibiotic choices that significantly decrease the pulmonary bacterial density of p. aeruginosa. a biofilm antimicrobial susceptibility assay thus has the ability to change the way antibiotics are chosen to treat cf patients and result in improved lung function and longer lives for all cf patients.

Eligibility criteria:
inclusion criteria: * diagnosis of cf based on the following: sweat chloride \> 60 meq/l or genotype with 2 identifiable mutations consistent with cf; and one or more clinical features consistent with cf * chronically infected with p. aeruginosa (\>50% of respiratory specimens positive for p. aeruginosa in the 24 months prior to screening) * able to produce sputum (expectorated or induced) * able to reproducibility perform pulmonary function testing * written informed consent provided exclusion criteria: * sputum culture negative for p. aeruginosa or with a density of less that 10\^5 cfu/g at screening * sputum culture positive for burkholderia cepacia at screening * history of b. cepacia positive respiratory culture within 24 months prior to screening * use of antibiotics other than those prescribed by the principal investigator * history of allergy (urticarial rash, diffuse erythroderma, serum sickness) to more than two groups of antibiotics (aminoglycosides, penicillins, cephalosporins, monobactams, macrolides, or quinolones) that are a therapeutic option * history of anaphylaxis or other life threatening complication to any antibiotic in the six groups that are a therapeutic option * post lung transplantation or listed for lung transplantation * pregnancy * a septic or clinically unstable patient * presence of a condition or abnormality that in the opinion of an investigator would compromise the safety of the patient or the quality of the data

Keywords: cystic fibrosis pseudomonas aeruginosa biofilm antibiotic susceptibility testing pediatrics
ttx-080 hla-g antagonist in subjects with advanced cancers

Conditions: Cancer

Summary: ttx-080-001 is a phase 1, open label, dose escalation and dose expansion clinical study to determine the safety, tolerability, and recommended phase 2 dose of ttx-080 monotherapy (hla-g inhibitor) and in combination with either pembrolizumab (pd-1 inhibitor), cetuximab (egfr inhibitor) or folfiri plus cetuximab (egfr inhibitor) in patients with advanced refractory / resistant solid malignancies including metastatic colorectal cancer (mcrc) patients.

ttx-080 is a fully human mab designed to block the interaction of hla-g with its known ligands, ilt2 and ilt4 molecules. the phase 1a was an open label, multicenter, dose escalation clinical trial to determine the safety, tolerability, mtd or obd, and the rp2d of ttx-080 when administered as a single agent. the phase 1b is a dose expansion of ttx-080 monotherapy and in combination with either pembrolizumab or cetuximab in adult subjects with advanced refractory/resistant solid malignancies, including head and neck squamous cell carcinoma (hnscc), non-small cell lung cancer (nsclc), colorectal cancer (crc), triple negative breast cancer (tnbc), renal cell carcinoma (rcc), and acral melanoma. additionally, the phase 1b includes randomized arms with ttx-080 in combination with folfiri plus cetuximab compared to folfiri plus cetuximab in metastatic colorectal cancer. the study will seek to evaluate the pharmacokinetics and immunogenicity of ttx-080, and characterize the anti-tumor activity of ttx-080 as a monotherapy and in combination with pembrolizumab, cetuximab or folfiri plus cetuximab.

Eligibility criteria:
abbreviated inclusion criteria: 1. subject with histological diagnosis of advanced/metastatic cancer 2. age 18 years or older, is willing and able to provide informed consent 3. evidence of measurable disease 4. eastern cooperative oncology group (ecog) performance status of 0 to 1 and life expectancy of at least 12 weeks abbreviated exclusion criteria: 1. history of allergy or hypersensitivity to study treatment components. subjects with a history of severe hypersensitivity reaction to any monoclonal antibody 2. use of an investigational agent within 28 days prior to the first dose of study treatment and throughout the study 3. receiving high-dose systemic steroid therapy or any other form of immunosuppressive therapy 4. history of severe autoimmune disease 5. uncontrolled intercurrent illness or other active malignancy requiring ongoing treatment

Keywords: hla-g ttx-080 advanced solid tumor cancer ovarian cancer endometrial cancer cervical cancer kidney cancer head and neck squamous cell carcinoma squamous cell lung cancer prostate cancer colorectal cancer gastric cancer breast cancer bladder cancer lung adenocarcinoma melanoma metastatic solid tumor renal cell carcinoma acral melanoma triple negative breast cancer pembrolizumab cetuximab antineoplastic agents, immunological antineoplastic agents head and neck cancer lung cancer
pixantrone as bridging therapy to allogenic transplant or car-t cell therapy in dlbcl patients

Conditions: Diffuse Large B Cell Lymphoma (DLBCL)

Summary: retrospective/prospective observational multicentric study aimed at describing the effectiveness of pixantrone as bridging therapy to allo-hsct or car-t therapy

the treatment of relapsed/refractory (r/r) diffuse large b-cell lymphomas (dlbcl) presents a challenge to physicians due to the lack of treatment options. pixantrone is an aza-anthracenedione, which, compared to anthracyclines and anthracenediones, has significantly reduced cardiotoxicity while maintaining good antitumour activity. the applications of pixantrone can be manifold: elderly patients with a second relapse who are unsuitable for transplantation or car-t cell therapy, young patients refractory to 2 previous lines of therapy as a bridge to autologous transplantation, bridge to allogeneic transplantation or car-t cell therapy, and salvage therapy for relapses after a transplantation or car-t approach. in particular, pixantrone could be one of the most suitable agents to link patients to car-t cell therapy due to its safety profile and its ability to induce a rapid response in patients sensitive to this agent. however, data in normal clinical practice are still lacking. hence the need for an italian multicentre collection to collect as many cases as possible of patients who have received pixantrone as a bridging therapy to allogeneic transplantation or car-t cell therapy.

Eligibility criteria:
inclusion criteria: 1. patients with relapsed or refractory dlbcl who received pixantrone as last line of therapy prior to allo-hsct or car-t cell therapy or patient's whose therapeutic program is treatment with pixantrone prior to allo-hsct or car-t cell therapy. 2. age ≥ 18 years at enrolment. 3. written informed consent (if applicable). exclusion criteria: 1) none

Keywords: pixantrone allogenic transplant car-t therapy